Acute Cardiovascular Events Triggered by COVID-19-Related Stress

Acute Myocardial Infarction Clinical Trial

— JoCORE  

Official title:

Acute Cardiovascular Events Triggered by COVID-19-Related, Non-infectious Stress The Jordan COVID-9 caRdiovascular Events (JoCORE) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368637
• Other study ID #: JCCG.JoCORE.4.4040
• Status: Recruiting
• Start date: May 3, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: May 2020
• Source: Jordan Collaborating Cardiology Group
• Contact: Ayman J Hammoudeh, MD, FACC
• Phone: 0096265001000
• Email: hammoudeh_ayman[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current COVID19 pandemic has afflicted almost the whole globe. The stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psychosocial stresses.

This study is a cross sectional study that will enroll patients evaluated during the COVID19 pandemic period for acute cardiovascular events.

Description:

The onset of acute myocardial infarction (AMI) is a complex interplay of internal circadian factors and external physical and emotional triggers. These interactions may lead to rupture of an often non-occlusive vulnerable atherosclerotic coronary plaque with subsequent formation of an occlusive thrombus. Physical and emotional stresses are important triggers of acute cardiovascular events including AMI. Triggering events, internal changes, and external factors vary among different geographical, environmental, and ethnic regions. Life-style changes, pharmacotherapy, and psychological interventions may potentially modify the response to, and protect against the effects of triggering events. Certain times in the life span of different communities all around the world are prone to natural and man-made disasters that, not only have direct negative impact on human lives and state-resources, but also have indirect impact on triggering acute cardiovascular events during the time of the disaster and the period immediately after. For example, earthquakes, wars, and terrorist attacks, in addition to direct human life loss and destruction of communities, have bees associated with a surge in the number of acute MI, sudden cardiac death, ventricular tachy-arrhythmia and implantable cardiovertor defibrillators (ICD) discharges.

The current COVID-19 pandemic has afflicted almost the whole globe. The virus can directly attack the myocyte and cause various degrees of cardiac damage and cardiovascular clinical entities. However, the stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psycho-social stresses such as extreme physical effort, lock down, anger, fear, financial stress, sorrow, death of a significant person..etc.

This study is a cross sectional study that will enroll patients evaluated during the COVID-19 pandemic period for acute cardiovascular events not directory related to the virus infectivity, who voice certain and specific trigger(s) related to the pandemic impact on social life and physical activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2020
• Est. primary completion date: July 30, 2020
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age >18 years.

• Acute MI (STEMI and NSTEMI).

• Sudden cardiac death

• Ventricular tachycardia

• ICD shocks.

• Stressful trigger prior to the cardiovascular event

Exclusion Criteria:

• COVID-19 infection.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Death
• Death, Sudden, Cardiac
• Infarction
• Myocardial Infarction
• Stroke
• Stroke, Acute
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Locations

Country	Name	City	State
Jordan	Abdelhadi Hospital	Amman
Jordan	Farah Hospital	Amman
Jordan	Istishari Hospital	Amman
Jordan	Jordan Hospital	Amman
Jordan	Specialty Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute cardiovascular event triggered by COVID-19 stress	Acute myocardial infarction as diagnosed by ST segment elevation or depression or inverted T wave on 12-lead EKG and elevated levels of cardiac troponins above the 99% of the normal values.; A. Acute MI (STEMI and NSTEMI). B. Aborted on non-aborted sudden cardiac death not attributed to a known etiology.; C. Sustained or non-sustained ventricular tachy-arrhythmia not attributed to a known etiology.; D. ICD shocks. 3. Absence of suspected or confirmed infection with the COVID19 virus. 4. Definite physical or psycho-social stressful trigger appearing in relation to the COVID-19 situation (lock down stress, financial stress, anger, depression, fear, sorrow, death of a significant person, eating binges, smoking binges, physical stress [carrying walking for shopping and carrying excess weights] ..etc) as judged by a unanimous agreement of three investigators in the steering committee.	4 months
Primary	Ventricular tachycardia	Typical ventricular tachycardia on 12-lead EKG or EKG monitor.	4 months
Primary	acute stroke	acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance	4 months
Primary	Implantable cardioverter defibrillator (ICD) shock	Finding an episode of ventricular tachycardia on interrogation of ICD tracing	4 months